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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04465903
Other study ID # 298
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 30, 2020
Est. completion date October 30, 2020

Study information

Verified date July 2021
Source Prof. Dr. Cemil Tascioglu Education and Research Hospital Organization
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Purpose of the study is the validity and reliability of the Turkish version of the Sydney Swallow Questionnaire (SSQ-T), so that it would be used as an assessment tool for Turkish dysphagia patients. Despite being translated and validated in many languages, there is no validated Turkish version of SSQ to measure the severity of oropharyngeal dysphagia.


Description:

The swallow function is a multidirectional process that depends on complex neuro-muscular network. The function can be evaluated using instrumental, such as fibreoptic endoscopic evaluation of swallowing (FEES), videofluoroscopy, or well structured questionnaires. There are many questionnaire and scales for assessment of swallow but very few have been validated. The study will assess the construct validity and reliability of the Turkish version of Self-report Symptom Inventory as known as Sydney Swallow Questionnaire. The investigators developed the Turkish version of this questionnaire (SSQ-T), according to the cross-cultural adaptation guidelines. Two translators translated the SSQ into Turkish and a native English language speaker reverse-translated it into English. The back translation was sent to the original author for proofreading. The SSQ questionnaire consisted of 17 basic questions related with dysphagia symptoms.


Recruitment information / eligibility

Status Completed
Enrollment 170
Est. completion date October 30, 2020
Est. primary completion date October 30, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: Group 1: - Able to speak, read, understand and write in Turkish - History of dysphagia during 6 months - Age between 18-80 years Group 2: - Able to speak, read, understand and write in Turkish - Healthy adults - Age between 18-80 years old. Exclusion Criteria: - Mental disorders - Cognitive limitations - Able not to speak, read, understand and write in Turkish - Underwent any surgery last a month - Underwent laryngectomy/neck dissection/tracheostomy/neck radiotherapy - Pregnancy - Malignancies - Out of age 18-80 years old.

Study Design


Intervention

Other:
Turkish Version of Sydney Swallow Questionnaire
The Turkish Version of Sydney Swallow Questionnaire consists of 17 questions related with dysphagia.

Locations

Country Name City State
Turkey Prof Dr Cemil Tascioglu City Hospital Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Prof. Dr. Cemil Tascioglu Education and Research Hospital Organization

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

Arenaz Búa B, Bülow M. Validation in Swedish of Sydney swallow questionnaire. BMC Res Notes. 2014 Oct 21;7:742. doi: 10.1186/1756-0500-7-742. — View Citation

Audag N, Goubau C, Danse E, Vandervelde L, Liistro G, Toussaint M, Reychler G. Validation and Reliability of the French Version of the Sydney Swallow Questionnaire. Dysphagia. 2019 Aug;34(4):556-566. doi: 10.1007/s00455-019-09978-9. Epub 2019 Feb 1. — View Citation

Dwivedi RC, St Rose S, Chisholm EJ, Georgalas C, Bisase B, Amen F, Kerawala CJ, Clarke PM, Nutting CM, Rhys-Evans PH, Harrington KJ, Kazi R. Evaluation of swallowing by Sydney Swallow Questionnaire (SSQ) in oral and oropharyngeal cancer patients treated w — View Citation

Wallace KL, Middleton S, Cook IJ. Development and validation of a self-report symptom inventory to assess the severity of oral-pharyngeal dysphagia. Gastroenterology. 2000 Apr;118(4):678-87. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Subject demographics The median values of age and ratio of gender in all groups Baseline
Primary Turkish Version of Sydney Swallow Questionnaire Turkish version of the questionnaire consists of 17 questions about dysphagia and swallowing functions and dysphagia consequences during patients at least six months and healty subjects. The minimum score is 0 and maximum score is 1700. The lower scores mean a normal swallowing function, higher scores mean worst oropharyngeal swallowing functions. Baseline
Primary Turkish Version of Sydney Swallow Questionnaire Turkish version of the questionnaire consists of 17 questions about dysphagia and swallowing functions and dysphagia consequences during patients at least six months. The minimum score is 0 and maximum score is 1700. The lower scores mean is a normal swallowing function, higher scores mean is worst oropharyngeal swallowing functions. 2 weeks
Secondary Eating Assessment Tool The Turkish validated questionnaire consists of 10 questions that scores are from 0 to 40. Low score is better, higher score is worse. Baseline
Secondary Penetration and aspiration scale The scale consists of 8 levels for assessment of penetration and aspiration. The scores are from 0 to 8. Low score is better, higher score is worse. Baseline
Secondary YALE scale of pharyngeal residue The scale consists of 5 assessment units for pharyngeal residue. The scores are from 1 to 5. Low score is better, higher score is worse. Baseline
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